A Clinical Trial of AP026 (TQA2226) for Injection in Adult Subjects.

NCT06143423 | Terminated Phase 1

• 1 other identifier: TQA2226-I-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a randomized, double-blind, placebo-controlled phase I clinical trial of AP026 (TQA2226) for injection in adult healthy subjects, which planned to recruit 74 healthy subjects. The main purpose was to evaluate the safety and tolerance of AP026 (TQA2226) for injection after single and multiple doses in healthy subjects.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events (AEs)

  Incidence of adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

  From patient enrollment to withdrawal, estimated up to 2 months.

• Severity of adverse events

  Severity of adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

  From patient enrollment to withdrawal, estimated up to 2 months.

• Incidence of serious adverse events (SAEs)

  Incidence of serious adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

  From patient enrollment to withdrawal, estimated up to 2 months.

• Severity of serious adverse events (SAEs)

  Severity of serious adverse events after dose, assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

  From patient enrollment to withdrawal, estimated up to 2 months.

Secondary Outcomes (14)

• Peak concentration (Cmax)

  SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.

• Plasma concentration-area under time curve (AUC0-t)

  SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.

• Plasma concentration-area under time curve (AUC0-∞)

  SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.

• Peak Time (Tmax)

  SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.

• Apparent volume of distribution (Vd/F)

  SAD: From 30 minutes before administration to 1176 hours after administration on Day 1. MAD: From 30 minutes before administration on Day 1 to 1008 hours after the last administration.

Study Arms (4)

AP026 (TQA2226) for injection Single administration dose (SAD)

EXPERIMENTAL

AP026 (TQA2226) for injection, administered once.

Drug: AP026 (TQA2226) for injection

AP026 (TQA2226) for injection matching placebo Single administration dose (SAD)

PLACEBO COMPARATOR

AP026 (TQA2226) for injection matching placebo, administered once.

Drug: AP026 (TQA2226) for injection matching placebo

AP026 (TQA2226) for injection Multiple administration dose (MAD)

EXPERIMENTAL

AP026 (TQA2226) for injection, administered 4 times.

Drug: AP026 (TQA2226) for injection

AP026 (TQA2226) for injection matching placebo Multiple administration dose (MAD)

PLACEBO COMPARATOR

AP026 (TQA2226) for injection matching placebo, administered 4 times.

Drug: AP026 (TQA2226) for injection matching placebo

Interventions

AP026 (TQA2226) for injection DRUG

AP026 (TQA2226) for injection is a GLP-1-FGF21-Fc bifunctional fusion protein.

AP026 (TQA2226) for injection Multiple administration dose (MAD); AP026 (TQA2226) for injection Single administration dose (SAD)

AP026 (TQA2226) for injection matching placebo DRUG

AP026 (TQA2226) for injection matching placebo is a placebo produced according to AP026 (TQA2226) for injection, and has no effect on GLP-1 and FGF21.

AP026 (TQA2226) for injection matching placebo Multiple administration dose (MAD); AP026 (TQA2226) for injection matching placebo Single administration dose (SAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign an informed consent form before the study and have a thorough understanding of the content, process, and potential adverse reactions of the study;
• Able to complete the study according to the requirements of the protocol;
• Subjects (including their partners) are willing to voluntarily take effective contraceptive measures within 6 months after the last study drug administration;
• Male and female subjects aged 18-55 (inclusive);
• Male subjects weighing no less than 50 kilograms and female subjects weighing no less than 45 kilograms, With a body mass index within the range of 18\~28kg/m2 (inclusive);
• Physical examination and vital signs are normal or abnormal but with no clinical significance (judged by the investigators).

You may not qualify if:

• Pregnant and lactating women;
• There are abnormal and clinically significant clinical laboratory examination results, or clinically significant diseases within 12 months before screening, which is not recommended to participate in the trial after evaluation by the investigators. Subjects with a previous medical history but are recovered with clinical evidence can be included in this study;
• During the screening period, any one of the vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, and other auxiliary examination results is abnormal and judged by the investigator to have clinical significance;
• Subjects who test positive for any of the hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (Anti HCV), human immunodeficiency virus antibody (Anti HIV), and Treponema pallidum antibody (Anti TP);
• Those who have undergone surgery within 4 weeks before screening or plan to undergo surgery during the study period;
• Received investigational drugs or participated in clinical trials within 3 months prior to screening;
• Received immunoglobulin or blood products within 30 days before randomization;
• Donated blood (\> 300 mL) or experienced significant blood loss (\> 400 mL) within 3 months prior to screening;
• Subjects with a history of needle sickness, blood sickness, or potential difficult in collecting blood;
• History of allergic reactions to other therapeutic monoclonal antibodies or biological agents, or history of allergies to multiple drugs or foods, especially to ingredients similar to the study drug;
• Smoking more than 5 cigarettes per day or using an equivalent amount of nicotine or nicotine containing products within 3 months before randomization, or failing to stop using any tobacco products during the trial period;
• Those who have been drinking excessively for a long time or have consumed more than 14 units of alcohol per week within 3 months before screening, or cannot abstain from alcohol during the trial period, or have tested positive for alcohol breath test;
• Subjects with a history of drug abuse, or positive urine drug screening;
• Received any commercially available or investigational biological agents within 4 months before randomization or within 5 half-lives of drugs (whichever is longer);
• Within 4 weeks before randomization, received any systemic prescription drugs, over-the-counter drugs, herbs, any vitamin products, and health products, or any topical drugs of the above forms at the injection site of this study;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130061, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: May 24, 2023
• Primary Completion: July 26, 2023
• Study Completion: March 16, 2026
• Last Updated: April 22, 2026

Record last verified: 2023-11

Locations

CN (1)